Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistMaster Sales LLC was warned for manufacturing and distributing hookah products without required premarket authorization, which constitute tobacco products under FDA jurisdiction regardless of nicotine source. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by not obtaining a marketing authorization order for these "new tobacco products" prior to commercial distribution in the United States. The FDA determined that hookah products containing nicotine—whether derived from tobacco or other sources—are subject to FDA regulation and cannot be legally marketed without premarket approval under section 910 of the Federal Food, Drug, and Cosmetic Act.